Agile: FDA has concerns on contraceptive

Agile Therapeutics, Inc., (Nasdaq: AGRX) announced the content of the official minutes from its Type A meeting with the U.S. Food and Drug Administration (FDA) held on April 16, 2018 to discuss the complete response letter (CRL) issued by the FDA on December 21, 2017 relating to the New Drug Application (NDA) for Twirla (AG200-15), the Company’s investigational low-dose, non-daily, combination hormonal contraceptive patch. In the CRL, the FDA informed the Company that the Twirla NDA could not be approved due to deficiencies related to the manufacturing process and facility for Twirla, and because of questions the FDA had on the in vivo adhesion properties of Twirla and their potential relationship to the Company’s Phase 3 clinical trial results.

In the official minutes, the FDA informed the Company that it continues to have significant concerns regarding the adhesion of Twirla, which the FDA believes cannot be addressed through the Company’s proposed patient compliance programs, and that the Company needed to address the Twirla adhesion properties by reformulating the transdermal system and conducting a formal adhesion study with the new formulation. The FDA also informed the Company that it would need to demonstrate bioequivalence to the data and information for the original formulation. The FDA advised the Company that after the Company satisfies the FDA’s questions on adhesion and adequately bridges to the findings in the SECURE Phase 3 trial, it anticipates discussing the safety and efficacy of Twirla at an advisory committee meeting to obtain input on whether the benefits outweigh the risks. In the absence of a finding of bioequivalence, the Company would need to conduct a new Phase 3 study with the new formulation. Finally, the FDA provided guidance on the path forward for addressing manufacturing issues related to Twirla, which path is largely based on the materials the Company had previously submitted in December 2017. To the extent that the Company reformulates Twirla, it may create the need for additional manufacturing work and review by the FDA.

“We believe we had a constructive meeting with the FDA, however, we disagree with the FDA’s conclusions on the adhesion of Twirla and our patient compliance programs. We believe we have demonstrated an adhesion profile for Twirla that supports approval based on extensive data from our Phase 2 studies, including an extreme conditions trial, and our three Phase 3 trials. We also believe that we have planned compliance and education programs that can address the issues raised by the FDA and will support patient use of the product once it is approved. While we will continue to evaluate all of our options on next steps, we expect we will pursue formal dispute resolution. We will provide an update when we move forward,” said Al Altomari, Chairman and Chief Executive Officer, Agile Therapeutics. “In light of the feedback from the FDA, we also are re-evaluating our business plan to identify ways to extend our ability to fund the Company’s operations,” concluded Mr. Altomari.

Company to Host Conference Call

Agile Therapeutics will host a conference call on May 18, 2018 at 8:00 a.m. Eastern Time to discuss the Company’s regulatory update. A question and answer session will follow Agile Therapeutics’ remarks. To participate on the live call, please dial (844) 413-1773 (domestic) or (678) 865-8976 (international), and provide the conference ID number: 5858819.

A live audio webcast of the call will be available via the “Investor Relations” page of the Agile Therapeutics website, http://www.agiletherapeutics.com. Please log on through Agile Therapeutics’ website approximately 10 minutes prior to the scheduled start time. A replay of the webcast will be archived on Agile Therapeutics’ website for 60 days following the call.

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